Job Summary:
We are seeking an experienced and detail-oriented Regulatory Affairs Officer to join our team in Oman. The ideal candidate will be responsible for managing regulatory submissions, ensuring product compliance with local health authority regulations, and maintaining up-to-date knowledge of evolving regulatory requirements, particularly with the Oman Ministry of Health (MOH).
Key Responsibilities:
- Prepare, compile, and submit product registration dossiers to the Oman Ministry of Health and other relevant regulatory bodies.
- Maintain current knowledge of regulations, guidelines, and standards relevant to pharmaceutical, medical device, or healthcare product registration in Oman.
- Ensure timely renewals, variations, and updates of licenses and product registrations.
- Liaise with internal departments (Quality, Manufacturing, R&D) to gather technical documents and support regulatory submissions.
- Communicate and coordinate with regulatory authorities to ensure smooth submission processes and resolve any queries.
- Monitor post-market regulatory requirements, including adverse event reporting, labeling compliance, and batch notification.
- Track and maintain accurate records of all regulatory activities and ensure compliance documentation is up to date.
- Support internal and external audits and inspections.
Requirements:
Bachelor's degree in pharmacy, Life Sciences, or a related field (master’s preferred).
- Minimum 5 years of experience in Regulatory Affairs within the pharmaceutical, medical device, or healthcare sector.
- Strong knowledge of Oman MOH regulations and submission processes.
- Oman MOH License preferred.
- Excellent written and verbal communication skills in English (Arabic is an advantage).
- Strong organizational skills, attention to detail, and the ability to manage multiple projects.
- Proficient in MS Office applications and regulatory databases.